SCIENTURE announces manufacturing and supply chain readiness for ArbliTM, (losartan potassium) Oral Suspension, 10mg/mL for a target product launch in July 2025.
Scienture Holdings (NASDAQ: SCNX) has announced manufacturing and supply chain readiness for Arbli™, their FDA-approved oral liquid losartan suspension (10mg/mL), targeting a commercial launch in July 2025. The company's subsidiary has partnered with Saptalis Pharmaceuticals for manufacturing and secured agreements for warehousing and distribution.
Arbli™ is the first and only FDA-approved ready-to-use oral liquid losartan in the U.S. market, designed for treating hypertension in patients over 6 years old, reducing stroke risk in hypertensive patients with left ventricular hypertrophy, and treating diabetic nephropathy in type 2 diabetes patients. The product holds two USPTO patents pending FDA Orangebook listing.
According to IQVIA data (MAT December 2024), the U.S. losartan market has annual sales of $292 million with 68 million prescriptions. Unlike current market offerings that require compounding from tablets, Arbli™ offers a ready-to-use liquid formulation with reduced dosing volume and room temperature storage stability.
Scienture Holdings (NASDAQ: SCNX) ha annunciato la preparazione per la produzione e la catena di approvvigionamento di Arbli™, la loro sospensione orale di losartan liquido approvata dalla FDA (10mg/mL), con lancio commerciale previsto per luglio 2025. La controllata dell'azienda ha stretto una partnership con Saptalis Pharmaceuticals per la produzione e ha siglato accordi per lo stoccaggio e la distribuzione.
Arbli™ è il primo e unico losartan orale liquido pronto all’uso approvato dalla FDA nel mercato statunitense, progettato per il trattamento dell'ipertensione in pazienti sopra i 6 anni, per ridurre il rischio di ictus nei pazienti ipertesi con ipertrofia ventricolare sinistra e per trattare la nefropatia diabetica nei pazienti con diabete di tipo 2. Il prodotto possiede due brevetti USPTO in attesa di inserimento nel FDA Orangebook.
Secondo i dati IQVIA (MAT dicembre 2024), il mercato statunitense del losartan registra vendite annuali di 292 milioni di dollari con 68 milioni di prescrizioni. A differenza delle offerte attuali che richiedono la preparazione da compresse, Arbli™ offre una formulazione liquida pronta all’uso con volume di dosaggio ridotto e stabilità a temperatura ambiente.
Scienture Holdings (NASDAQ: SCNX) ha anunciado la preparación para la fabricación y la cadena de suministro de Arbli™, su suspensión oral líquida de losartán aprobada por la FDA (10mg/mL), con un lanzamiento comercial previsto para julio de 2025. La subsidiaria de la empresa se ha asociado con Saptalis Pharmaceuticals para la fabricación y ha asegurado acuerdos para almacenamiento y distribución.
Arbli™ es el primer y único losartán líquido oral listo para usar aprobado por la FDA en el mercado estadounidense, diseñado para tratar la hipertensión en pacientes mayores de 6 años, reducir el riesgo de accidente cerebrovascular en pacientes hipertensos con hipertrofia ventricular izquierda y tratar la nefropatía diabética en pacientes con diabetes tipo 2. El producto cuenta con dos patentes USPTO pendientes de inclusión en el FDA Orangebook.
Según datos de IQVIA (MAT diciembre 2024), el mercado estadounidense de losartán tiene ventas anuales de 292 millones de dólares con 68 millones de prescripciones. A diferencia de las ofertas actuales que requieren preparar la medicación a partir de tabletas, Arbli™ ofrece una formulación líquida lista para usar con menor volumen de dosis y estabilidad a temperatura ambiente.
Scienture Holdings (NASDAQ: SCNX)는 FDA 승인 경구용 액상 로사르탄 현탁액(10mg/mL)인 Arbli™의 제조 및 공급망 준비를 발표했으며, 2025년 7월 상업 출시를 목표로 하고 있습니다. 회사의 자회사는 제조를 위해 Saptalis Pharmaceuticals와 협력했으며, 창고 보관 및 유통 계약도 체결했습니다.
Arbli™는 미국 시장에서 FDA 승인된 최초이자 유일한 즉시 사용 가능한 경구용 액상 로사르탄으로, 6세 이상 환자의 고혈압 치료, 좌심실 비대가 있는 고혈압 환자의 뇌졸중 위험 감소, 제2형 당뇨병 환자의 당뇨병성 신병증 치료를 위해 설계되었습니다. 이 제품은 FDA Orangebook 등재를 대기 중인 두 건의 USPTO 특허를 보유하고 있습니다.
IQVIA 데이터(MAT 2024년 12월 기준)에 따르면 미국 로사르탄 시장은 연간 매출 2억 9,200만 달러와 6,800만 건의 처방을 기록하고 있습니다. 기존 시장 제품은 정제에서 조제해야 하는 반면, Arbli™는 복용량이 적고 상온에서 안정적인 즉시 사용 가능한 액상 제형을 제공합니다.
Scienture Holdings (NASDAQ : SCNX) a annoncé la préparation de la fabrication et de la chaîne d'approvisionnement pour Arbli™, leur suspension orale liquide de losartan approuvée par la FDA (10 mg/mL), visant un lancement commercial en juillet 2025. La filiale de la société s'est associée à Saptalis Pharmaceuticals pour la fabrication et a conclu des accords pour le stockage et la distribution.
Arbli™ est le premier et unique losartan liquide oral prêt à l'emploi approuvé par la FDA sur le marché américain, conçu pour traiter l'hypertension chez les patients de plus de 6 ans, réduire le risque d'accident vasculaire cérébral chez les patients hypertendus avec hypertrophie ventriculaire gauche, et traiter la néphropathie diabétique chez les patients atteints de diabète de type 2. Le produit détient deux brevets USPTO en attente d'inscription au FDA Orangebook.
Selon les données IQVIA (MAT décembre 2024), le marché américain du losartan affiche un chiffre d'affaires annuel de 292 millions de dollars avec 68 millions d'ordonnances. Contrairement aux offres actuelles qui nécessitent une préparation à partir de comprimés, Arbli™ propose une formulation liquide prête à l'emploi avec un volume de dose réduit et une stabilité à température ambiante.
Scienture Holdings (NASDAQ: SCNX) hat die Produktions- und Lieferkettenbereitschaft für Arbli™ bekannt gegeben, ihre von der FDA zugelassene orale flüssige Losartan-Suspension (10 mg/ml), mit einem geplanten Markteintritt im Juli 2025. Die Tochtergesellschaft des Unternehmens hat eine Partnerschaft mit Saptalis Pharmaceuticals für die Herstellung geschlossen und Vereinbarungen für Lagerung und Vertrieb gesichert.
Arbli™ ist das erste und einzige von der FDA zugelassene gebrauchsfertige orale flüssige Losartan auf dem US-Markt, entwickelt zur Behandlung von Bluthochdruck bei Patienten über 6 Jahren, zur Reduzierung des Schlaganfallrisikos bei hypertensiven Patienten mit linksventrikulärer Hypertrophie und zur Behandlung der diabetischen Nephropathie bei Typ-2-Diabetikern. Das Produkt verfügt über zwei USPTO-Patente, die auf eine Aufnahme in das FDA Orangebook warten.
Laut IQVIA-Daten (MAT Dezember 2024) hat der US-Losartan-Markt einen Jahresumsatz von 292 Millionen US-Dollar mit 68 Millionen Verschreibungen. Im Gegensatz zu den derzeitigen Angeboten, die eine Herstellung aus Tabletten erfordern, bietet Arbli™ eine gebrauchsfertige flüssige Formulierung mit reduziertem Dosierungsvolumen und Stabilität bei Raumtemperatur.
- First and only FDA-approved ready-to-use liquid losartan in U.S. market
- Two USPTO patents pending FDA Orangebook listing
- Targeting large market with $292M annual sales and 68M prescriptions
- Manufacturing and distribution partnerships secured for July 2025 launch
- Addresses unmet need in liquid formulation market
- Product launch still pending (not generating revenue yet)
- Will face competition from established losartan tablet manufacturers
- to specific patient population requiring liquid formulation
Insights
Scienture's manufacturing readiness for Arbli marks a significant milestone toward commercializing the only FDA-approved liquid losartan in a $292M market with patent protection.
Scienture's announcement of manufacturing and supply chain readiness for Arbli represents a crucial milestone in the company's commercialization timeline. As explicitly stated in the article, Arbli is the first and only FDA-approved ready-to-use oral liquid losartan in the U.S. market, addressing a gap in treatment options for patients who cannot take solid dosage forms. The company has secured its manufacturing partnership with Saptalis Pharmaceuticals, which has confirmed possession of the necessary materials and capabilities to produce launch quantities for the targeted July 2025 commercial release.
The market opportunity is substantial, with IQVIA data showing losartan generates
The product's intellectual property position appears strong, with two issued patents from the USPTO that are expected to be listed in the FDA Orangebook. This patent protection creates an important competitive advantage for Scienture in the losartan market. The company has also established strategic partnerships for warehousing and distribution through various wholesalers, completing the supply chain requirements for commercial launch.
Arbli's approved indications include hypertension in patients over 6 years old, stroke risk reduction in hypertensive patients with left ventricular hypertrophy, and treatment of diabetic nephropathy in certain type 2 diabetes patients. This broad label allows Scienture to address multiple patient populations with a single formulation.
Manufacturing readiness for Arbli reduces execution risk for Scienture's entry into the $292M losartan market, potentially transformative for this small-cap pharmaceutical company.
Scienture's confirmation of manufacturing and supply chain readiness for Arbli represents a critical de-risking event in the product's commercialization pathway. For a company with a market capitalization of only
The announcement confirms three essential components for a successful product launch: 1) manufacturing capability through Saptalis Pharmaceuticals, 2) warehousing agreements, and 3) distribution pathways through various wholesalers. This infrastructure readiness indicates the company is executing effectively on its pre-launch strategy for the targeted July 2025 commercial release.
Arbli's status as the only FDA-approved liquid losartan formulation creates a unique market position that may support favorable pricing and reimbursement. The two issued patents provide intellectual property protection that could exclude potential competitors and preserve market share once launched.
From a financial perspective, the most significant aspect of this announcement is the reduction in execution risk. Supply chain readiness increases confidence in the company's ability to meet its July 2025 launch target. For a small-cap pharmaceutical company, maintaining development and launch timelines is particularly crucial as delays can significantly impact financial projections and capital requirements.
While the announcement doesn't provide specific revenue projections or market share targets, the established market size of 68 million prescriptions annually demonstrates substantial commercial potential for this novel formulation that addresses an unmet need in the treatment landscape.
TAMPA, FL, April 22, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to patients, physicians and caregivers through developing, bringing to market, and distributing novel specialty products to satisfy unmet market needs, is pleased to announce the initiation of supply chain activities by its wholly owned subsidiary Scienture, LLC to manufacture launch quantities of ArbliTM (losartan potassium) Oral Suspension, 10 mg/mL for the intended commercial launch of the product in July 2025. Scirenture, LLC’s contract manufacturing partner, Saptalis Pharmaceuticals, LLC for ArbliTM has indicated to Scienture that Saptalis has the materials and capabilities to produce the batches and supply product inventory in time for the target commercial launch. In addition, Scienture, LLC has also entered into agreements with strategic partners for warehousing and distributing the product to the market through various wholesalers.
ArbliTM is meant for the treatment of hypertension in patients greater than 6 years old, for the reduction of risk of stroke in patients with hypertension and left ventricular hypertrophy and for the treatment of diabetic nephropathy in certain patients with type 2 diabetes. ArbliTM is the first and only FDA approved ready-to-use oral liquid losartan in the U.S. market.
ArbliTM is a novel proprietary formulation of losartan, a proven therapy for treating hypertension, which provides a tailored approach to patients that require or prefer an oral liquid option of losartan. Appropriate dosing is now easier, safe and effective, while providing the assurance of quality as an FDA-approved product. ArbliTM provides a safe and convenient option to patients requiring a liquid formulation and addresses the intrinsic risks associated with potential inconsistencies in the process of crushing tablets to extemporaneously compound losartan prescriptions. ArbliTM has two issued patents from the USPTO, which are also expected to be listed in the FDA Orangebook.
Losartan is classified as an angiotensin receptor blocker (ARB) for treating hypertension and is one of the highest prescribed molecules for this indication. Current products in the market containing losartan are available only as oral solids, which can be further compounded to a liquid formulation. ArbliTM is the first liquid formulation of losartan on the market that does not require compounding and has reduced dosing volume and long-term shelf life at room temperature storage. IQVIA data (MAT December 2024) indicates a total annual sales of approximately
“Achieving manufacturing and distribution readiness for the targeted launch in July 2025 of ArbliTM, is a testament to the hard work of our cross-functional teams and the strength of our production infrastructure partnership” said Narasimhan Mani, President of Scienture, LLC. “We are now in a strong position to support the timely access of ArbliTM for patients and caregivers and deliver value to our stakeholders.”
“Our manufacturing and supply chain readiness in support of the commercial launch of ArbliTM , reflects not only our technical capabilities but also our commitment to the highest standards of quality, compliance, and patient safety,” remarked Shankar Hariharan, CEO of Scienture, LLC. “This marks a pivotal milestone in our mission to deliver therapeutic benefit to patients in need.
About ArbliTM
ArbliTM is the first and only oral liquid formulation of losartan approved by the U.S. FDA. Arbli™ comes in a 165 mL bottle as a peppermint flavored suspension that does not require refrigeration, and has been approved for a shelf life of 18 months from the date of manufacture when stored at room temperature, based on the data submitted in the NDA. Once the 24-months stability data is submitted to the FDA, the shelf-life of the product is expected to be extended to 24-months at room temperature.
INDICATION
ArbliTM is an angiotensin II receptor blocker (ARB) indicated for:
- Treatment of hypertension, to lower blood pressure in adults and children greater than 6 years old. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
- Reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy.
- Treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension.
IMPORTANT SAFETY INFORMATION
- Do not take ArbliTM when pregnant. When pregnancy is detected, discontinue ArbliTM as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ArbliTM can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death.
- Do not co-administer ArbliTM with aliskiren in patients with diabetes. Avoid use of aliskiren with ArbliTM in patients with renal impairment (GFR <60 mL/min).
- Do not administer ArbliTM in patients with severe hepatic impairment. ArbliTM has not been studied in patients with severe hepatic impairment.
- The most common adverse reactions are (incidence ≥
2% and greater than placebo): dizziness, upper respiratory infection, nasal congestion, and back pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Scienture at 1-833-754-4917.
Please see the full Prescribing Information for complete product information. For more information, talk to your healthcare provider.
About Hypertension
Hypertension (high blood pressure) is a cardiovascular condition, when the pressure in the blood vessels is too high (140/90 mmHg or higher). According to the CDC, hypertension, or high blood pressure, affects nearly half of adults in the United States, or 119.9 million people. Hypertension is defined as a systolic blood pressure of 140 mmHg or higher, and diastolic blood pressure of 90 mmHg or higher. Hypertension is a risk factor for stroke and heart disease, which are leading causes of death in the U.S. Factors that increase the risk of having high blood pressure include: older age, genetics, being overweight or obese, not being physically active, high-salt diet and drinking too much alcohol. Hypertension is clinically diagnosed if, when blood pressure is measured on two different days, the systolic blood pressure readings on both days is ≥140 mmHg and/or the diastolic blood pressure readings on both days is ≥ 90 mmHg.
About Scienture Holdings, Inc.
SCIENTURE HOLDINGS, INC. (NASDAQ: “SCNX”), is the parent company of its wholly owned subsidiary, Scienture, LLC a branded, specialty pharmaceutical company consisting of a highly experienced team of industry professionals who are passionate about developing and bringing to market unique specialty products that provide enhanced value to patients and healthcare systems. The assets in development at Scienture, LLC are across therapeutics areas, indications and cater to different market segments and channels. For more information please visit and www.scientureholdings.com.
Cautionary Statements Regarding Forward-Looking Statements
This press release contains certain statements that may be deemed to be “forward-looking statements” within the federal securities laws, including the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Statements that are not historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements relate to future events or our future performance or future financial condition. These forward-looking statements are not historical facts, but rather are based on current expectations, estimates and projections about our company, our industry, our beliefs and our assumptions. Such forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, including for the products we may launch, the timing of such launches, and the success those products may have in the marketplace. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” or the negative of these terms or other similar expressions, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements are subject to a number of risks and uncertainties (some of which are beyond our control) that may cause actual results or performance to be materially different from those expressed or implied by such forward-looking statements. Accordingly, readers should not place undue reliance on any forward-looking statements. These risks include risks relating to agreements with third parties; our ability to raise funding in the future, as needed, and the terms of such funding, including potential dilution caused thereby; our ability to continue as a going concern; security interests under certain of our credit arrangements; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; claims relating to alleged violations of intellectual property rights of others; the outcome of any current legal proceedings or future legal proceedings that may be instituted against us; unanticipated difficulties or expenditures relating to our business plan; and those risks detailed in our most recent Annual Report on Form 10-K and subsequent reports filed with the SEC.
Forward-looking statements speak only as of the date they are made. Scienture Holdings, Inc. undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise that occur after that date, except as otherwise provided by law.
Contact:
SCIENTURE HOLDINGS, INC.
6308 Benjamin Rd, Suite 708
Tampa, Florida 33634
Phone: (866) 468-6535
Email: IR@Scienture.com
FAQ
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